Catalog Number RONYX27538X |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that the catheter part of the resolute onyx was broken during the procedure.The metal stent was not broken.It was stated that the balloon was inflated but the stent was not implanted in the patient.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The lesion was calcified.The lesion was pre-dilated.The device was not inspected before use.Resistance was not noted during delivery or withdrawal of the device to/from the lesion site.Sufficient time given to the balloon to deflate prior attempting to remove the device from the patient.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During a procedure an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a lesion.It was reported that the stent was broken during the procedure.The procedure was completed using another resolute onyx rx stent.No patient injury was reported.
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Manufacturer Narrative
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Product analysis summary: several kinks were visible on the hypotube.There was a detachment on the hypotube distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.No deformation was evident to the distal tip.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the distal stent wraps with struts raised and flattened respectively.Multiple kinks were noted on the distal shaft and inner member.The core wire was kinked.The inner lumen patency could not be verified with a 0.015 inch mandrel most likely due to damage to the inner member.There was no other damage evident to the remainder of the device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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